Supervisor, QA Review and Release at Mylan Inc
Posted in Other 30+ days ago.
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Type: Full Time
Location: Morgantown, West Virginia
For Us, It\'s A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:
* Supervise the day-to-day business needs of the QA Review and Release group (i.e., copying the daily production schedules, copying lab release requirements for the team, etc.)
* Establish priorities and ensure that they are attained for the QA Review and Release group on a daily basis as required by production, packaging and customer service. These priorities will be utilized to establish the daily schedule that maintains the flow of products as well as projects through the review group.
* Communicate, assist, and answer questions from the QA release officers, AQL Coordinators, manufacturing and packaging personnel, customer service, management, QA Investigations, Tech Support specialists and auditors regarding the QA Review/Release area and responsibilities.
* Coordinate and also perform the final review on all documentation (Production, Packaging, QC Certificate of Analysis, QA Physical Data, etc.) prior to providing the approval to ship the drug product restricted or full release to the distribution center.
* Conduct weekly audits of batches pending QC Release to Pack, including Validation lots.
* Maintain controlled approved documents utilized by QA Review and Release pulled from the Quality repository.
* Initiate and revise standard operating procedures (SOPs) as needed.
* Author and conduct training sessions, and work with the Quality Training representative to retrieve a training session and MyUniversity number.
* Troubleshoot and perform investigations on problems arising in R&D, Manufacturing, Quality and Packaging documentation. Initiate, author, and approve incident and investigation reports.
* Ensure work area is inspection ready at all times. This includes, but is not limited to, all controlled approved documents posted in work areas are the most current/effective version (repository), all procedures posted are within the allotted 24-hour time frame, and each employee maintains an organized and clean work area as well as oversight of the general area.
* Maintain ownership of MBOs and KPIs.
* Perform other duties as assigned.
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.
Must possess strong knowledge of SOPs, GMPs, Manufacturing, Packaging and the IR process.
Must possess knowledge of computer programs. Must understand and adhere to company and departmental policies and procedures as well as government regulations.
Must possess good written and oral communication skills, math and problem solving skills, interpersonal skills, meticulous attention to details and a working knowledge of the ERP System, LIMS, Tackwise, Microsoft Word, and Microsoft Excel.
Position functions semi-autonomously.
Position directly supervises employees.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities may include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
Proficiency in speaking, comprehending, reading and writing English is preferred.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.
Job Posting: Jun 13, 2018, 11:09:50 AM
Unposting Date: Ongoing.